Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto:
Schedule
Product: Vioxx
Active Ingredient: Rofecoxib 2.5mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, Merck West Point, Pennsylvania, United States of America
Product: Vioxx
Active Ingredient: Rofecoxib 5mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Vioxx
Active Ingredient: Rofecoxib 12.5mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Vioxx
Active Ingredient: Rofecoxib 25mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Product: Vioxx
Active Ingredient: Rofecoxib 50mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia
Dated this 7th day of October 2003.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the
6th day of July 2001).